Outreach: A Programme for Timely Treatment of Critically Ill Patients in a University Hospital

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00306345
First received: March 22, 2006
Last updated: July 11, 2007
Last verified: February 2007

March 22, 2006
July 11, 2007
January 2006
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Complete list of historical versions of study NCT00306345 on ClinicalTrials.gov Archive Site
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Outreach: A Programme for Timely Treatment of Critically Ill Patients in a University Hospital
Outreach: A Programme for Early Recognition, Quick Response and Timely Treatment of Critically Ill Patients in a University Hospital

The identification of patients with potential early organ failure is the key in preventing admission or readmission to a critical care facility. The primary goal of the Outreach Project is to ensure that all patients with threatening organ failure receive appropriate and timely treatment in a suitable area; avoid admission to the intensive care unit (ICU); and share ICU skills by a partnership in education. The objectives of the study are to determine whether the introduction of an intensive care unit based medical emergency team, responding to hospital-wide preset criteria of physiologic instability, will decrease the number of predefined serious adverse events (SAEs) and to investigate the effects on quality of life and costs in a general surgery population.

Study Hypothesis: The Outreach intervention will decrease the number of predefined serious adverse events; increase quality of life; and decrease costs.

DESIGN: A multi centre longitudinal intervention trial with a before and after design in a university hospital.

The INTERVENTION consists of three parts:

  1. The introduction of a hospital-wide intensive care unit based medical emergency team to evaluate and treat patients deemed at risk for developing an adverse outcome.
  2. Education and training of ward staff in the recognition and basic management of patients developing a critical illness.
  3. The development of an intensive care (nurse and physician staffed) consultancy service for general wards.

STUDY POPULATION: The population for this study consists of patients undergoing major general surgery with an admission stay of more than 48 hours. It includes patients undergoing central or peripheral vascular surgery, major oncological surgery, lung surgery, major abdominal surgery and trauma surgery.

MEASUREMENTS AND OUTCOMES: In total, 1500 patients will be included. (750 Patients in the control period and 750 patients in the intervention period). Measurements include the incidence of Serious Adverse Events, HRQoL (Quality of life EQ-5D), costs of care and ICU logistics.

TIME-SCHEDULE: Data collection starts January 1, 2006 and stops no later than three months after the inclusion of 1500 patients or April 1, 2008. The final report of the study will be in December 2008.

Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
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  • Patient Centered Care
  • Postoperative Care
  • Critical Illness
Behavioral: Outreach
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
December 2008
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Inclusion Criteria:

  • Major general surgery.
  • Admitted to the hospital 48 hours after surgical intervention

Exclusion Criteria:

  • Not able to communicate in the Dutch language.
  • Younger than 18 years old.
  • Pregnancy
Both
18 Years and older
No
Contact: Gerrit Bloo, Master 0031 24 3665011 g.bloo@caiocb.umcn.nl
Contact: Ton Haans, Master 0031 24 3665012 a.haans@ic.umcn.nl
Netherlands
 
NCT00306345
001, CMO 301
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Radboud University
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Principal Investigator: Hans van der Hoeven, Professor UMCN
Radboud University
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP